Improving Function Through Primary Care Treatment of PTSD

Posttraumatic Stress Disorder Clinical Trial

— PE-PC  

Official title:

Improving Function Through Primary Care Treatment of PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581981
• Other study ID #: D2625-R
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 12, 2022

Study information

• Verified date: January 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed project will examine a promising brief therapy for PTSD for use in VHA Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD treatment and improved function that does not require referral to specialty mental health and accomplishes improved function in a short-term, brief protocol. Many Veterans prefer to receive mental health care, including PTSD service in primary care. The current protocol would allow them to access effective therapy options in addition to the medication management that is currently the standard of care for PTSD in primary care. In addition, this brief protocol may reduce the number of specialty mental health referrals as many Veterans may not require additional PTSD specific treatment after completion. Thus, if effective, this protocol will greatly increase Veteran treatment choice and improve functional outcomes and access while also increasing efficiency of allocation of specialty PTSD services.

Description:

Posttraumatic stress disorder (PTSD) is a debilitating and costly mental health issue (Greenberg, Sisitsky et al. 1999, Hoge, Terhakopian et al. 2007). RAND reported an estimated two-year cost of $4.0 to $6.2 billion US dollars for mental health issues from the current conflicts in Iraq and Afghanistan and further estimated that providing evidence-based treatments for PTSD and depression could save an estimated $86.2 million (Tanielian, et al. 2008). Even modest reductions in PTSD severity have been related to increased probability of positive function outcomes (Smith, et al. 2005). Prolonged Exposure (PE) therapy (Foa, et al. 2000, Foa, et al. 2005, Schnurr, et al. 2007) is an effective, first-line treatment for PTSD (IOM 2007, VA/DOD 2010). While highly effective, PE is provided in specialty mental health settings typically in 8 to 15, weekly 90 minute individual sessions. Veterans with PTSD are often reluctant to seek care in specialty mental health, and, as a result, many are treated solely in primary care and do not have access to this effective intervention (Possemato, et al. 2011). While the DoD and VA have actively integrated behavioral health providers into their primary care clinics (Maguen, et al. 2010, Seal, et al. 2011), current behavioral interventions for PTSD in primary care are often inconsistent with clinical practice guidelines and/or not effective (Possemato, et al. 2011). Since functional outcomes are critical, the investigators intend to extend beyond assessing the impact of PE-PC on clinical outcomes to function. Thus, there is a clear and urgent need to further develop, validate, and disseminate evidence-based psychotherapeutic treatments for PTSD in integrated VHA PC-MHI with a focus on functional outcomes. To fill this need and gap in care the study investigators developed a Brief Prolonged Exposure for Primary Care (PE-PC) treatment protocol with 4, 30-minute sessions for use in a stepped care model. A pilot study in military treatment facilities found PE-PC resulted in reductions in PTSD that were maintained at 6- and 12-month follow-up (Cigrang, et al, 2015). Preliminary results from a randomized controlled trial (RCT; PI: Cigrang; CoI: Rauch) of PE-PC compared to minimal attention control (MAC, including continuation of any PC initiated treatment) found a significantly larger reduction in PTSD severity (measured by PCL) in PE-PC than MAC (between group d = .78, p = .01). The strength of these initial findings is limited by lack of functional outcomes and examination of impact in VHA. While Service Members and Veterans have many similarities, potential differences in motivation for treatment and other factors may influence the efficacy of the protocol especially when examining changes in function. The proposed study will randomize 120 Veterans at Ralph H. Johnson VAMC presenting in primary care with PTSD who meet minimal inclusion/exclusion criteria to 6 weeks of PE-PC or PC-MHI-treatment as usual (TAU). Recruitment will occur over 36 months. All Veterans will complete a baseline assessment prior to randomization and post-treatment follow-up assessments at Weeks 6, 12, and 24 post-randomization. Primary outcome will be function assessed as self-reported role function in several domains. In addition, the investigators will examine symptoms severity and effectiveness, acceptability, and utilization associated with PE-PC or PCMHI-TAU in the 6 months prior to randomization and 6 months following treatment completion. PE-PC may allow access to effective treatment and efficient allocation of PTSD specialty treatment resources in the VHA. This topic is of key relevance to Veteran mental health care and can provide a new access point for high quality PTSD care to improve function allowing many more Veterans to experience improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any era Veterans seeking care in VA PC for PTSD symptoms (PCL-5 28) and PTSD confirmed based on CAPS

• English speaking

• Report significant impairment in function related to PTSD symptoms as noted on intake WHODAS

• Report that they want treatment for PTSD

• If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment

Exclusion Criteria:

• Other primary clinical issue that would interfere with PTSD treatment

• Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS (46)) that requires:

• PTSD + interested and consent to study

• PCP Screen:

• PC-PTSD + Intake

• PCMHI Provider:

• [PCL 28] + brief interview

• No PTSD OR

• Not interested in treatment OR

• Not interested in study

• Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen

• Psychosis or unmanaged bipolar disorder

• Moderate to severe substance use disorder in the past 8 weeks

• Patients who are currently receiving talk therapy for trauma-related symptoms

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure for Primary Care (PE-PC)
Brief version of PE provided in 30 minute sessions in PC
• Treatment as Usual
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Ralph H. Johnson VA Medical Center, VA Ann Arbor Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (2)

McLean CP, Back SE, Capone C, Morland L, Norman SB, Rauch SAM, Schnurr PP, Teng E, Acierno R. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research. J Trauma Stress. 2022 Feb;35(1):308-313. doi: 10.1002/jts.22718. Epub 2021 Jul 22. — View Citation

Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K, Cigrang J. Improving function through primary care treatment of PTSD: The IMPACT study protocol. Contemp Clin Trials. 2022 Sep;120:106881. doi: 10.1016/j.cct.2022.106881. Epub 2022 Aug 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	World Health Organization Disability Assessment Scale Change	Change in total score between time points	Week 0 to Week 6
Primary	World Health Organization Disability Assessment Scale	total score with higher scores indicating more impairment and scores above 40 indicating clinically significant functional impairment in a VA PTSD population	Week 12
Primary	World Health Organization Disability Assessment Scale	total score with higher scores indicating more impairment and scores above 40 indicating clinically significant functional impairment in a VA PTSD population	Week 24
Secondary	Clinician Administered PTSD Scale for DSM 5 (CAPS5) Change	Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established	Week 0, 6, 12, 24
Secondary	PTSD Checklist for DSM5 (PCL-5) Change	Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established	Week 0, 6, 12, 24
Secondary	Patient Health Questionnaire- 9 (PHQ-9) Change	Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+	Week 0, 6, 12, 24
Secondary	Clinician Administered PTSD Scale for DSM 5 (CAPS5)	Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established	Week 12
Secondary	Clinician Administered PTSD Scale for DSM 5 (CAPS5	Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established	Week 24
Secondary	PTSD Checklist for DSM5 (PCL-5)	Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established	Week 12
Secondary	PTSD Checklist for DSM5 (PCL-5)	Total score ranges from 0 to 80 with higher more severe; cut points for this measure have not yet been established	Week 24
Secondary	Patient Health Questionnaire- 9 (PHQ-9)	Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+	Week 12
Secondary	Patient Health Questionnaire- 9 (PHQ-9)	Total score ranges from 0 to 27 with higher more severe; Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+	Week 24